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Midterm report on 2025 network strategy highlights good progress during critical period of the pandemic

The European medicines regulatory network is on track to meet its strategic goals and objectives covering availability and accessibility of medicines; data analytics, digital tools, and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply-chain challenges; sustainability of the network and operational excellence, according to the midterm report of the network strategy. “Despite the unprecedented challenges presented by the COVID-19 pandemic and the resource that has been deployed across the medicines regulatory network in response, a lot of progress has been made in the six priority focus areas of our network strategy,” says Emer Cooke, EMA’s Executive Director. “The end of the public health emergency and the lifting of the business continuity planning means we will once again be in a position to focus more fully on delivering patient-relevant medicines and digital transformation while continuing to deal with health threats and supply issues.” The network strategy was published ...
- Source: drugdu
- 139
- December 25, 2023
Shanghai RAAS Cancels Limited Payment Scope of Medical Insurance for Some Products

According to the official website of the State Medical Insurance Bureau, in order to further improve the level of medication protection for the insured, in accordance with the Interim Measures for the Administration of Medicines for Basic Medical Insurance and the Requirements of the Work Program for Adjustment of the National Drug Catalogs for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance for the Year of 2023, the State Medical Insurance Bureau and the Ministry of Human Resources and Social Security have organized to adjust and formulate the “Drug Catalog (2023)” for the National Drug Catalog (2023)”, which was officially implemented from January 1, 2024 onwards. This catalog includes human albumin, IVIG (intravenous human immunoglobulin), human fibrinogen, human plasminogen complex, human coagulation factor VIII, human coagulation factor IX, human immunoglobulin, tetanus human immunoglobulin, human rabies immunoglobulin, and recombinant human coagulation factor VIIa, recombinant human coagulation factor VIII, and recombinant ...
- Source: drugdu
- 81
- December 25, 2023
“National Key Laboratory for R&D of New Vaccines for Emerging Infectious Diseases” was launched!

On December 20, the kick-off meeting of “National Key Laboratory for R&D of New Vaccines for New Emerging Infectious Diseases” and the first meeting of the first Academic Committee were held at Sinopharm China Biologicals. Deng Jindong, Vice General Manager of Sinopharm and Chairman of China Bio, and Yang Xiaoming, Chief Scientist and Chief Engineer of Sinopharm, Chief Scientist of China Bio, and Director of the National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases, formally launched the “National Key Laboratory for R&D of Novel Vaccines for Newly Emerging Infectious Diseases”. Academician Zhao Jia, Academician Chen Xiangmei, Academician Li Zaikun, and Academician Wang Junzhi of the Chinese Academy of Engineering attended the launching meeting. After the launching meeting, the National Key Laboratory of New Vaccine Development for Emerging Infectious Diseases held the first meeting of the first academic committee. The Academic Committee listened to and passed ...
- Source: drugdu
- 83
- December 25, 2023
Apple to pause US sales of smartwatches with pulse oximetry

Dive Brief Apple will pause selling models of the Apple Watch in the U.S. that have blood oxygen monitoring functions, beginning this week, the company told the website 9to5Mac. The move comes nearly two months after the U.S. International Trade Commission (USITC) ordered Apple to stop importing and selling its watches with the pulse oximetry feature in response to a patent infringement complaint brought by patient monitoring company Masimo. Apple, in a statement carried by 9to5Mac, said that it was “preemptively” taking steps to comply with the USITC ruling while it awaits the outcome of a presidential review of the order. The time period for President Joe Biden to review the decision is set to expire on Dec. 25. Dive Insight Masimo, which sells a competing medical watch, accused the tech giant of stealing its trade secrets and incorporating its patented technology for measuring blood oxygen saturation into some Apple ...
- Source: drugdu
- 141
- December 22, 2023
Accurate Blood Markers for Identifying AKI Could Eliminate Need for Invasive Kidney Biopsies

Acute Kidney Injury (AKI) is a condition characterized by intense inflammation, leading to sudden kidney function loss. AKI affects an estimated 15% to 20% of hospitalized patients, increasing their risk of in-hospital death and possibly leading to chronic kidney disease requiring dialysis or transplant. Clinicians have long sought markers to detect AKI without resorting to invasive kidney biopsies. Now, researchers have used cells from kidney biopsies to make progress in the search for more accurate and easier-to-obtain markers that can predict, manage, and assess the treatment of AKI. This new study by investigators at Johns Hopkins University (Baltimore, MD, USA) focused on noninvasive assessments of what is termed maladaptive proximal tubule (PT) repair, a process that occurs in response to AKI and is marked by excessive inflammation. This PT maladaptation process offers an opportunity to identify noninvasive markers in blood or urine that could greatly aid in predicting AKI, managing ...
- Source: drugdu
- 198
- December 22, 2023
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies

Pharmaceutical Executive Editorial Staff If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies. The FDA has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of allergic reactions, such as anaphylaxis, that may result from an accidental exposure to one or more foods in patients aged 1 year and older with a food allergy. If the FDA approves the application, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure. Roche said it expects the FDA to decide on the approval in the first quarter of 2024. “Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global ...
- Source: drugdu
- 102
- December 22, 2023
GSK Expands Again in Cancer, Paying Hansoh $185M for Another ADC

GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024. By FRANK VINLUAN GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a ...
- Source: drugdu
- 204
- December 22, 2023
Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has scored a full FDA endorsement for the oral, delayed-release drug. Tarpeyo becomes the first treatment fully approved in the United States specifically for the chronic autoimmune kidney condition, also known as Berger’s disease. While some graduations from accelerated to full approval are ceremonial, this endorsement carries extra weight as it expands the label for Tarpeyo, allowing it to be accessed by all patients with IgAN. Perviously, the FDA limited the med’s use to those at risk for rapid disease progression. The expansion was facilitated by a confirmatory trial, which was the first phase 3 IgAN study to show significant improvement in estimated glomerular filtration rate (eGFR), which is the most reliable measure of kidney function. The results showed that Tarpeyo can reduce the time to kidney failure by 30%, potentially ...
- Source: drugdu
- 214
- December 22, 2023
Palatin sells female libido drug Vyleesi to Cosette for $12M, plus more in potential milestones

In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market. The new buyer for Vyleesi, which was approved by the FDA in 2019, is another New Jersey drugmaker, Cosette Pharmaceuticals, which also is on the hook for $159 million in contingent, sales-based milestones. As one of two drugs hailed to potentially become the “female Viagra,” Vyleesi has not lived up to expectations. In September, when Palatin revealed its quarterly earnings, it reported fiscal-year sales of $12.5 million, compared to $5.8 million in the previous fiscal year. While Palatin CEO Carl Spana, Ph.D., said in a release that he was “excited” that Vyleesi’s net product revenue ...
- Source: drugdu
- 211
- December 22, 2023
Kunming Plasma Products, a subsidiary of China National Pharmaceutical Group (Sinopharm), has been selected for the list of Intelligent Manufacturing Demonstration Factories in 2023.

The announcement, jointly released by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission of the State Council, and the State Administration for Market Regulation, highlights Kunming Plasma Products’ achievement in intelligent manufacturing by making it to the ‘2023 Intelligent Manufacturing Demonstration Factories’ list. This recognition marks a new milestone in Kunming Plasma Products’ efforts towards intelligent manufacturing and digital factory construction. As a crucial component of China’s ’14th Five-Year Plan’ Intelligent Manufacturing Pilot Demonstration Action, the national-level Intelligent Manufacturing Demonstration Factories and Outstanding Scenes are part of a major national project led jointly by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the State-owned Assets Supervision and Administration Commission of the State Council, the Ministry of Finance, and the State Administration for Market Regulation. The initiative aims to select ...
- Source: drugdu
- 202
- December 22, 2023

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